Why is this study being done?
The purpose of this study is to test whether a new cell phone application called Be Zesty, helps women manage the stress and symptoms that might happen when they get chemotherapy for breast cancer
Who is paying for this study?
The Susan G. Komen Breast Cancer Foundation is paying for the costs of this study, including part of the salaries for Drs. Nápoles and Stewart.
How many people will take part in this study?
About 140 people from two to three clinics located in the San Francisco Bay Area will take part in this study
What will happen if I take part in this research study?
If you agree, the following procedures will occur:
- COMPLETE AN IN-PERSON BASELINE INTERVIEW: You will complete an initial interview which should take about 60 minutes. The research staff will interview you in-person in a private location at the clinic where you receive treatment or at another location you prefer. The research staff will ask you about your health, well-being, and breast cancer.
- BE ASSIGNED TO A RESEARCH GROUP: After the baseline interview, you will be assigned to one of two groups. This will be determined by chance. That is, you will have a 50/50 chance (like flipping a coin) as follows:
- IF YOU ARE ASSIGNED TO THE NO APP GROUP: If you are assigned to the group that does not get the cell phone app, the following will take place:
-You will not use the Be Zesty app.
-You will receive written chemotherapy material from the study. The research staff will briefly review it with you at the baseline interview.
- IF YOU ARE ASSIGNED TO THE BE ZESTY APP GROUP: If you are assigned to the group that gets the Be Zesty app the following will take place:
-Meet in-person with the research staff and receive 45-minute training on how to use the Be Zesty app, cell phone, and review written chemotherapy materials. This meeting can take place on the same day as the baseline interview or 3 to 5 days after the baseline interview, whichever is convenient to you.
-If you do not have a cell phone, do not have the right type of cell phone, or prefer not to install the Be Zesty app on your personal cell phone, the research staff will loan you a study cell phone and charger to use during the 6-month study.
-If you prefer, we may be able to install the Be Zesty app on your personal cell phone and remove it from your personal cell phone at the end of the study.
-You will receive written material on chemotherapy.
-You will use the Be Zesty app every day for 6-months.
-You will be asked to use the Be Zesty app every day to respond to messages about how you are feeling and to review your daily progress, which takes a few minutes.
-You will receive information on chemotherapy and stress management on the app. The Be Zesty app will also suggest ways to manage your symptoms and reduce your stress.
-You will have 7 phone calls with the health coach. Each call will last about 15-20 minutes each week for 7 weeks. Each week the health coach will focus on the different components of the Be Zesty app.
-You will receive phone calls from the study team to address any problems with the Be Zesty app.
- COMPLETE THREE ADDITIONAL TELEPHONE INTERVIEWS: One interview will be in 3 months from now and another one will be in 6 months. Each of these should take about 20-30 minutes and will ask about your health and well-being. If you were assigned to the Be Zesty group, you will also do a 5 minute telephone interview when you complete the Be Zesty app program. It will ask for your opinions about the app.
- COLLECT MEDICAL INFORMATION: During the study, the research staff will collect your medical information from your medical records, or they may ask you to obtain these records and give them to the study staff. This will include information about your breast cancer and breast cancer treatment.
- STUDY PHONE AND EQUIPMENT: The cell phone provided by the research staff is to be used primarily for accessing the cell phone app for this study.
-You will be given 70 free minutes per week to talk with friend and family in the United States. You will receive a text message when you are getting close to this limit. If you go over the 70 free minutes per week you may not receive your payment at the end of the study. We will also contact you on this cell phone during the study period.
-If you purchase a ring tone and/or game for your own interest, you will be responsible to pay these costs.
-You will be asked to return the study cell phone and charger to the research staff immediately after completing the 6 month interview or when withdrawing from the study.
Your 6 month payment will not be processed until you return the cell phone and charger to the research staff, if you borrowed it. If any equipment is lost, it will need to be located and returned to the UCSF research office before any payment will be made. If the cell phone is reported stolen, a report may be filed with the UCSF police department.
-If you decide to use your own cell phone for the study and need to add an unlimited text message service and/or unlimited data plan to your monthly cell phone plan, you will be reimbursed for all additional study-related expenses including federal tax. You will be asked to bring your telephone bills at the 6 month visit and payment will be sent to you.
At the end of the study or at the time you withdraw from the study, it is your responsibility to contact your cell phone company and cancel these additional unlimited text messaging and/or unlimited data plans.
How long will I be in the study?
Your participation in the study will last about 6 months.
- If you are assigned to the group that does not get the Be Zesty app your participation in the study will take on average about 2.5 hours total for the interviews.
- If you are assigned to the group that uses the Be Zesty app your participation in the study will take on average about 26 hours total including the interviews, daily reporting of symptoms via the cell phone, viewing Be Zesty information, meeting with research staff to review the app content and chemotherapy materials, and completing 7 phone calls with the health coach.
Can I stop being in the study?
Yes. You can decide to stop being in the study at any time. Just tell the study researcher or staff person as soon as possible if you wish to stop being in the study. The study researcher can end your participation in the study if the study researcher decides that:
- your participation is not in your best interest
- if you do not follow the study rules
- if the study is stopped before the allotted time
- if you abuse the cell phone service provided by the research staff
What side effects or risks can I expect from being in the study?
Side effects or risks include:
- You will be able to skip any questions or stop the interview at any time if you feel too uncomfortable.
- You may end any telephone calls or appointments with research staff at any time if talking with them about your breast cancer makes you feel uncomfortable or sad.
- For more information about risks and side effects, ask one of the researchers.
Benfits to taking part in the study?
The possible benefit of your participation in this study is that you will be tracking your daily symptoms, which could help you manage your breast cancer symptoms. We also hope the information learned from this study will help us develop other cell phone programs like this one for people with similar health needs.
What other choices do I have if I do not take part in this study?
Your other choice is to not participate in the study and refuse to receive the cell phone program. If you decide not to participate in this study, you will not lose any of your regular health care benefits, and you can still get your care from your health care provider the way you usually do.
Will information about me be kept private?
Yes. Participation in research may cause a loss of privacy, but we will do our best to make sure that the personal information gathered for this study is kept as confidential as possible. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.
Organizations that may look at and/or copy your research records for research, quality assurance, and data analysis include: The University of California.
What are the costs of taking part in this study?
None. You will not be charged for taking part in this study.
Will I be paid for taking part in this study?
You will be paid up to a $100 in cash for taking part in this study as follows:
- $25 in cash for the 60-90 minute first in-person interview and overview of the chemotherapy materials and overview of the Be Zesty app (if you are in the Be Zesty group) (today).
- $25 in cash for the 20-30 minute 2nd interview by phone (in 3 months).
- $10 in cash for the 5 minute interview, which will be done by phone when you finish the Be Zesty program (in 3 months).
- $40 in cash for the 20-30 minute last interview by phone (in 6 months). If you are using a cell phone and charger provided by the study team, these items must also be returned prior to receiving study payment.
What are my rights if I take part in this study?
Your participation in this study is voluntary. Even if you decide to participate, you may leave the study at any time. No matter what decision you make, there will be no penalty to you. You will not lose any of your regular health care benefits, and you can continue to get your care from your regular health care provider the way you usually do.
Who can answer my questions about the study?
You can talk to the researcher(s) about questions, concerns, or complaints you have about this study. Contact the researcher(s):
- Jasmine Santoyo-Olsson at (415) 514-3355
- Anna Nápoles at (415) 476-6290
- Anita Stewart at (415) 502-5207.
If you wish to ask questions about the study or your rights as a research participant to someone other than the researchers or if you wish to voice any problems or concerns you may have about the study, please call the Office of the Committee on Human Research at (415) 476-1814.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.